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510(k) Data Aggregation
K Number
K223681Device Name
Respiree Cardio-Respiratory Monitor
Manufacturer
Respiree PTE Ltd.
Date Cleared
2023-03-08
(90 days)
Product Code
BZQ, BZO
Regulation Number
868.2375Why did this record match?
Applicant Name (Manufacturer) :
Respiree PTE Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Respiree Cardio-Respiratory Monitor is a respiratory monitor intended for hospital-type facilities in non-ICU settings. The Respiree Cardio-Respiratory Monitor is indicated for the non-invasive spot checking of respiration rate (RR) for adult patients.
Device Description
The Respiree Cardio-Respiratory Monitor, Model RS001, is a small respiratory monitor. For measurement of respiration rate (RR), the device is affixed to the chest using a disposable adhesive patch with a hook-and-loop fastener to attach to the monitor. The device uses a vertical-cavity surface-emitting diode to emit optical radiation directed toward the skin. An integrated photodetector in a nearby position senses the diffused collected light. An adaptive signal processing method is used to enhance the device respiratory rate measurements by splitting the signal processing optimizations across different respiratory rate bands.
The monitor is powered by a 3.7V rechargeable, lithium-ion battery and a USB charging cable is provided. The Respiree Cardio-Respiratory Monitor also includes optional Bluetooth wireless technology for the wireless transfer of patient data to mobile devices.
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